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Food and
Drug Administration
Hematology and Pathology Devices
July 18, 2008
BRIEFING INFORMATION
FDA
Disclaimer
Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. §552). These redacted portions will appear as white space on the screen or on the printed page.
FDA Executive Summary and Panel Questions (pdf)
Hematology Spurious results (pdf)
IVD Characteristics (pdf)
Bibliography of Literature for ADCC panel (pdf)
ADCC Information for panel (pdf)